BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2936243 · Received January 30, 2013

    Report

    Report Number
    2124215-2013-02057
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 3, 2012
    Report Date
    August 25, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBSEQUENTLY EXPLANTED DUE TO A PATIENT UPGRADE. UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION FOUND NO IRREGULARITIES. ADDITIONALLY, A REVIEW OF THE MEMORY LOG FOUND NO IRREGULARITIES. THE DEVICE WAS ATTACHED TO A 500 OHM PACING LOAD AND NO NOISE OR OVERSENSING WAS OBSERVED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE LOCAL FIELD REPRESENTATIVE THAT THERE WERE NO ADVERSE PATIENT EFFECTS OBSERVED RELATING TO THE HIGH BRADY RATE PACING. THE PHYSICIAN STATED THEY SAW LEFT VENTRICULAR (LV) PACING BY THE V1 VECTOR ON THE ECG WHILE DOING THE ABATION. NO ALLEGATION OF MALFUNCTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ABLATION PROCEDURE, HIGH BRADY RATE PACING WAS OBSERVED. EXTRA PACING SPIKES FOR AN UNKNOWN REASON WAS ALSO BEING OBSERVED WHILE THE DEVICE WAS OPERATING IN ELECTRO MODE. A REQUEST FOR ADDITIONAL INFORMATION WAS SENT TO THE LOCAL FIELD REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40184 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R H135| 0148| 4513| 4047| N119| 4054| H215